Pre-agreed update rules so an MCED test is not obsolete when its trial reads out
A cancer blood test improves every year, but a ten-year trial tests the old version. Regulators and sponsors could agree in advance how updates are validated and carried into the result.
FDA's Predetermined Change Control Plan for AI devices offers a model. Propose an MCED-specific plan: the classifier may be updated on banked baseline samples under locked-test-set rules, each version must be shown non-inferior on a sequestered set, and the primary analysis uses the enrolment version with a pre-specified sensitivity analysis re-scoring banked plasma.
- Most lethal cancers are found late · Screening exists for only a few cancers. Pancreatic, ovarian, liver, oesophageal and most lung cancers are found when cure is unlikely.
- AI that is built but not validated or deployed · Thousands of cancer AI models are published; a handful are in clinical use, and fewer have shown they help patients.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaMulti-cancer blood test as the first step for patients with non-specific symptoms
Shares GRAIL, Multi-cancer early detection (MCED), Most lethal cancers are found late.
- IdeaLet MCED trials read out on late-stage incidence, with mortality follow-up mandated
Shares PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED), Most lethal cancers are found late.
- Key paperPATHFINDER: the first prospective test of a multi-cancer blood test in people without symptoms
Shares PATHFINDER 2, NHS-Galleri, DNA methylation profiling, Multi-cancer early detection (MCED).
- CompanyHarbinger Health
Shares DNA methylation profiling, Multi-cancer early detection (MCED), Most lethal cancers are found late.
- ProductGalleri
Shares GRAIL, PATHFINDER 2, NHS-Galleri, DNA methylation profiling.
- IdeaA whole-population cancer interception programme: risk-stratify every adult, detect and intercept early
Shares PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED), Most lethal cancers are found late.
- Key paperNHS-Galleri: design of the largest randomised trial of a multi-cancer blood test
Shares PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED), Most lethal cancers are found late.
- InstitutionPrince of Wales Hospital / Chinese University of Hong Kong
Shares GRAIL, DNA methylation profiling, Multi-cancer early detection (MCED).